1INITIA L STATEMEN T OF REASONS
CALIFORNIA ENVIRONMENTA L PROTECTION AGENCY  
OFFICE  OF ENVIRONMENTA L HEALTH HAZARD ASSESSMENT
TITLE  27, CALIFORNIA CODE  OF REGULATIONS
PROPOSED ADOPTION O F NEW  CHAPTER AND SECTION
CHAPTER 3: NATURALLY  OCCURRING  LEAD IN CANDY
SECTION 28500: NATURALLY  OCCURRING  LEVEL S OF LEAD IN CANDY 
JUNE 2020
Summary
Health and Safety Code section 1105521 require s the Office of Environmental 
Health Hazard Asses sment  (OEHHA),  in consultation with the California 
Department  of Publi c Health (CDPH)  and the Office of the Attorney  General 
(OAG) , to determine the “naturally  occurring level” of lead in candy  containing 
chili and tamarind . Pursuant  to this requirement,  OEHHA  is propos ing to add Title 
27 of the California Code of Regulations,  Chapter 3: Naturally Occurring Lead in 
Candy,  section 28500,  Naturally Occurring Level s of Lead in Candy.  The 
proposed regulation establishes a level for naturally  occurring lead in candies 
flavored with chili and/or tamarind,  based on a scientifi c approac h summarized in 
this document  and discussed in detail in the attached scientifi c analysis titled 
Naturall y Occurring Lead in Certain Candies .  Candies Flavored with Chili and/or 
Tamarind (OEHHA  2020)2.
Purpose and Background of P ropose d Regulation
The purpose of this regulation is to establish a naturally occurring level of  lead in 
candies containing chili and tamarind,  as required by section 110552(c)( 3). 
OEHHA  initially proposed a naturally occurring level of  lead in these candies on 
Marc h 15, 2019 (hereafter,  “the 2019 proposed rulemaking”),  but was unable to 
complete the proposed rulemaking within the one-year statutory timeframe.   
While the proposed level ha s not changed,  OEHHA  has incorporated additional 
information received during the comment  period for the 2019 proposed 
rulemaking into this Initial Statement  of Reason s and the attached technical 
support  document.  
1 Hereafter referred to as “section 110552” or “the Statute”.
2 Hereafter referred to as “Technical Support Document”.Page 2 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500The attached technical support document lays out the detailed scientific 
approach and analysis supporting the proposed regulatory leve l.  A summary of 
the approach is  provided below .
Approach  for establishing the naturally occurring level  of lead in candie s 
containing chili or tamarind
OEHHA developed an ingredient -based approach to estimate the sum of 
naturally occurring lead in candy containing chili and tamarind, based on an 
evaluation of the level of naturally occurring lead plausibly contributed by a g iven 
ingredient and amounts of each such ingredient typically present in these 
candies. The approach is as follows:
·Identify candies flavored with chili or tamarind,
·Identify other ingredients, other than chili and tamarind, that may
substantially contribute to naturally occurring lead in these candies,
·Evaluate the level of naturally occurring lead that could reasonably
be contributed by each such ingredient, and
·Estimate the level of naturally occurring lead in these candies by
accounting for the amount contributed by each lead -containing
ingredient typically present in the candies.
Each of the following has been identified as a potential contributor to naturally 
occurring lead in candies flavored with chili and/or tamarind: 
·Chili peppers and chi li powder3
·Tamarind
·Food -grade salt
·Sugar
·Food -grade silicon dioxide
·Food -grade titanium dioxide
Chocolate -based  candies  are not within the scope of the current proposed 
regulation. 
For each substance identified as a potential contributor of naturally occurring 
lead in candies flavored with chili or tamarind, OEHHA has determined  a level of 
lead that is considered naturally occurring consistent with section 110552 , and 
3 “Chili powder” here refers to a product made primarily from milled chili peppers of the genus 
Capsicum , rather than the commonly available spice mix also called chili powder containing 
milled chili peppers together with other ingredients , e.g., cumin, oregano, and garlic.    Page 3 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500used these levels to determine the proposed regulatory level of naturally 
occurring lead in candies flavored with chili and/or tamarind . 
As required by the statute, the proposed regulatory level was determined in 
consultation with CDPH and OAG.
Proposed Regulatory Standard
OEHHA is proposing to add the following new chapter and section to Title 27 of 
the California Code of Regulations:
CHAPTER 3. NATURALLY OCCURRING LEAD IN CANDY
§ 28500. Naturally Occurring Levels of Lead in Candy
For purposes of  Health and Safety Code section 110552(c)(3),  the 
following levels of lead in candy are deemed by the Office of 
Environmental Health Hazard Assessment  to be naturally occurring:
Type of Candy Naturally -Occurring 
Level (parts per million)
Candies flavored with  chili and /or tamarind 0.02 ppm
Details on the basis for the proposed level are provided in the attached Technical 
Support Document .
Necessity
The proposed regulation is  necessary to set a standard for naturally occurring 
levels of lead in candies containing chili and tamarind  as require d by Health and 
Safety Code section 110552(c)(3).
Economic Impact Assessment Required by Gov. Code section 11346.3(b) 
In compliance with Government Code section 11346.3, OEHHA has assessed all 
the elements pursuant to sections  11346.3(b)(1)(A) through (D) .
Creation or elimination of jobs within the State of California
The proposed regulation would establish a new  naturally occurring level for lead 
in candies containing chili and /or tamarind .  The existing default level is 0.10 
ppm, which was determined by the California Attorney General as part of a 2006 
consent judgment in a Proposition 65 enforcement action, People v. Alpro 
Alimento Proteinicos (Los Angeles County Superior Court Case #BC318207 and Page 4 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500related cases)4.  The proposed naturally occurring level i s 0.02 ppm.  This 
regulatory action will not significantly impact the creation or elimination of jobs 
within the State of California. 
California Candy Manufacturers
Most manufacturers of candies containing chili and/or tamarind are located 
outside of Cali fornia, with many located in Mexico.   OEHHA  used information 
available from public databases, industry publications, and trade organizations 
(e.g., The National Confectioners Association  (NCA) )5to identify candy 
companies in California  that produce candies containing chili and/or tamarind6. 
OEHHA identified f ewer than ten California candy manufacturers that currently 
produce any candies containing chili and/or tamarind.  These California 
manufacturers are likely already  in compliance with the proposed naturally 
occurring level, based on recent past performance of th ese types of candies in 
monitoring studies conducted by CDPH7and an evaluation of recent data for 
similar candies provided by manufacturers in Mexico8. 
None of the  identified California  manufacturers of  candies flavored with chili 
and/or tamarind have  had a product  with detectable lead reported by CDPH in at 
least the last six years9.  Further, lead was detected in only seven individual 
candy samples  of the more than 1,000 samples of any cand ies or related 
products tested by CDPH since January 2015.  Of these seven samples  with 
lead detected by CDPH , only two potentially contained chili and/or tamarind, and 
4 Pursuant to section 110552(c)(3), until OEHHA adopts regulations determining the naturally 
occurring level of lead in candy, “the Attorney General’s written determination, if any, including 
any determination set fo rth in a consent judgment entered into by the Attorney General…shall be 
binding for purposes of this section.”
5 Shumow, Laura.  2017. Written comments submitted on behalf of the National Confectioners 
Association in response to the Center for Environemtna l Health petition for rulemaking 
determining the “naturally occurring” level of lead in candy containing chili and tamarind, p. 2. 
Submitted by Laura Shumow, Vice President, Scientific and Regulatory Affairs, NCA, July 19, 
2017.
6 Limited public information is available  on many smaller California candy manufacturers, since  
many of these small er manufacturers are independent  operations with limited to no advertis ing, 
social media , or internet presence, and some appear to operate only as contract manufacturers 
or on  a seasonal basis . 
7 CDPH. 2018. Lead in Candy Testing Data. Available at 
www.cdph.ca.gov/Programs/CEH/DFDCS/Page s/FDBPrograms/FoodSafetyProgram/LeadInCan
dy.aspx .
8 Technical Support Document, pp. 31-33.
9 CDPH. 2018. Lead in Candy Testing Data. Available 
atFwww.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/LeadInC
andy.aspx .Page 5 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500these were manufactured outside of the United  States and imported to California.  
Based on th ese data and trends  showing that detectable levels of lead in candy 
were more common  in earlier years of the CDPH monitoring program , it is 
reasonable to expect that California manufacturers  are already sourcing 
ingredients of high quality , low lead concentration  and would therefore  not be 
significantly impacted by the proposed level .
For any manufacturer that might be impacted, OEHHA believes this proposed  
naturally occurring level is achiev able with minimal cost to the manufacturer by 
following good agricultural, manufacturing, and procurement practices, or by 
other currently feasible practices .  For example, the lead in chili powder can be 
significantly reduced by washing the chili peppers before processing and 
employing simple and relatively low -cost drying procedures10.  As of 2008, there 
was an approximately $1.60 (USD) per kilogram cost difference for Mexican 
candy manufacturers to purchase higher grade chili peppers to produce chili 
powd er with less lead content11.  This would be the equivalent of an increase in 
cost ranging from fractions of a cent per candy to no more than three cents per 
candy for a typical sugar- based product containing chili flavor .
California Candy Retailers
California retailers are not likely to incur additional costs or face difficulty in 
obtaining candy products containing  chili and/or tamarind that meet the proposed 
lead level of 0.02 ppm , because  as discussed above based on CDPH 
surveillance data Californ ia manufacturers do not have detectable levels of lead 
in their products.  Similarly, CDPH surveillance data indicate most  imported 
candies flavored with chili and/or tamarind produced by  Mexican manufactu rers 
do not have detectable levels of lead .  Thus t he proposed level will not result in 
any significant economic impact on California businesses  including the creation 
or elimination of jobs in California .
OEHHA has reviewed test results for levels of lead present in candies containing 
chili and/or tamarind that were produced by multiple manufacturers in Mexico .  
Data from testing of candies produced by nine differen t manufacturers between 
2012 and 2017 for sale into  California indicate that 87% of the tested candies 
had lead concentrations at or below 0.020 ppm.  Further, only three candies were 
10 Technical Support Document, pp.4-13.
11 Sumner, Wil. 2008. CA OEHHA Mexican Candy Workshop. Slide Presentation by Wil Sumner, 
Sumner Analytical Services, Consultant  to the California Attorney General’s Office. Los Angeles, 
CA:  March 6, 2008. Workshop Transcript, 56 -57.Page 6 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500reported to contain more than 0.030 ppm lead, and  no candy was reported to 
contain more than 0.034  ppm lead12.  Additional d ata from testing conducted 
between 2017 and 2018 of candies containing chili and/or tamarind produced by 
one of the larges t candy manufacturers in Mexico  that is a party to the Alpro 
Alimento  consent judgement13indicate that  94% of these candies  had lead 
concentrations at or below  0.02 ppm.  Given that the vast majority of Mexican 
candies flavored with chili and/or tamarind are already in compliance  with the 
proposed level of 0.02 ppm , and that Mexico is a leading producer of such 
candies, most i mporters , distributors  or retailers of these candies in California are 
already sourcing compliant candies from Mexican manufacturers.  Further, as the 
majority of candies flavored with chili and/or tamarind manufactured by both 
California and Mexican manuf acturers offered for sale in California are already 
compliant with the proposed regulation, California retailers of these candies are 
unlikely to be significantly impacted.
Creation of new businesses or elimination of existing businesses within 
the State of California
For the reasons noted above, this proposed  regulatory action will not impact the 
creation of new businesses or the elimination of existing businesses within the 
State of California because very few California manufacturers exist, and none are  
anticipated to be unab le to comply with the proposed standard.  Further, of 
candies produced by Mexican manufacturers that were tested between 2012 and 
2017 for compliance with the current standard of 0.10 ppm, none of the candies 
exceeded th at level, and  approximately 87% to 94% would be complian t with the 
proposed level  of 0.02 ppm.
Expansion of businesses currently doing business within the State of 
California
This regulatory action will not impact the expansion of businesses within the 
State of Califor nia.  There are very few California manufacturers that produce the 
type of candies covered by this proposed regulation .  Over  the past several years 
CDPH has not reported any detectable lead in chili or tamarind containing candy 
product s produced by California manufacturers14.  As discussed above, data 
12 Technical Support Document, pp. 31-33.
13 Technical Support Document, pp. 31-32.
14 CDPH. 2018. Lead in Candy Testing Data. Available at 
www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/LeadInCan
dy.aspx .Page 7 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500from testing of candies produced in Mexico by nine different manufacturers 
offered for sale in California indicate that 87% of the tested candies had lead 
concentrations at or below 0.020 ppm.  Further,  only three candies were reported 
to contain more than 0.030 ppm lead, and no candy was reported to contain 
more than 0.034 ppm lead15. 
Benefits of the proposed regulation to the health and welfare of California 
residents, worker safety, and the state’s environment
The proposed regulation would  establish  a naturally occurring level of lead in 
candie s containing chili and tamarind  for the purpose of enforcing other 
provisions of the law related to the sale or distribution of adulterated candy within 
Califo rnia.  The proposed regulation will therefore benefit the health and welfare 
of California residents by setting a scien ce-based naturally occurring level that 
will be used to ensure that candy sold or distributed in California is not 
adulterated  with lead .
Technical, Theoretical, and/or Empirical Study, Reports, or Documents 
Relied Upon 
The scientific basis for the naturally occurring level of lead in candy containing 
chili and tamarind is outlined in the technical support document included with this 
Initial Statement of Reasons and titled Naturally Occurring Lead in Certain 
Candies.  Candies Flavored with Chili and/or Tamarind  (OEHHA 2020).  Citations 
to documents and other materials relied on for establishing this standard are 
provided in the technical su pport document.  Copies of these documents and 
other materials will be included in the regulatory record  for this action, and are 
available from OEHHA upon request.  In considering the potential impact of the 
proposed regulation, OEHHA also reviewed materi als presented by an industry 
consultant during a 2008 public workshop16and the results of analyses 
conducted by CDPH as part of the CDPH Food and Drug Branch monitoring and 
enforcement activities to prevent the sale of adulterated candy in California17.  No 
other technical, theoretical or empirical material was relied upon by OEHHA in 
proposing the adoption of this regulation.
15 Technical Support Document, pp. 31 -33.
16 Sumner, Wil. 2008. Lead in Mexican Candy: Report Summary of the audits and
investigation by Wil Sumner , SA Services. Slide Presentation by Wil Sumner, Sumner Analytical 
Services. Los Angeles, California: March 6, 2008. 
17 CDPH. 2018. Lead in Candy Testing  Data. Available at 
www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/FoodSafetyProgram/LeadInCan
dy.aspx  Page 8 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500Reasonable Alternatives to the Regulation and the Agency’s Reasons for 
Rejecting Those Alternatives
Health and Safety Code secti on 110552 requires OEHHA to determine the 
naturally occurring level of lead in candy containing chili and tamarind and 
publish that level in regulation.   Pursuant to this mandate, OEHHA developed an 
ingredient -based approach to estimate the sum of naturall y occurring lead in 
candy containing chili and tamarind, which is described ab ove and, in more 
detail, in the OEHHA 2020 Technical Support Document.
One alternative to the proposed naturally occurring level is to continue with the 
current default level tha t was determined by the Attorney General as part of a 
consent judgment in 2006.  However, c ontinuing with the current default level 
would allow candies to be sold in California that contain lead levels that can be 
feasibly reduced. 
Multiple commenters on the 2019 proposed rulemaking  stated that the proposed 
naturally occurring level is too low.  In some cases, these commenters submitted 
data that they believe supports adopting a hig her naturally occurring level. To the 
extent  this data is relevant to this proposed rulemaking, it is addressed in the 
updated Technical S upport Document.  One commenter, NCA, stated that 
OEHHA’s approach does not sufficiently account for inherent variability and 
recommended that OEHHA set the natur ally occurring regulatory level based on 
an average subject to an outlier limitation, such as the allowance of single 
sample maximums at 150% of the compliance level in the 2006  Alpro Alimento  
consent judgment .  After reviewing the relevant comments and da ta received on 
the 2019  rulemaking proposal , OEHHA has determined that the submitted 
information and  data do not  support changing the previously proposed  naturally 
occurring level  of 0.02 ppm .
Some commenters  on the 2019 proposed rulemaking  recommended different  
lead level limits for specific ingredients in candies containing chili and tamarind  
based on an apparent  misunderstanding that OEHHA’s proposed regulation was 
setting naturally occurring levels for individual ingredients in candy rather than 
the candy as  a whole.  For example,  one commenter,  Frudest , recommended a 
level of lead in c hili powder  between 0.120 and 0.180 ppm .  However,  OEHHA is 
not establishing naturally occurring lead levels for individual candy ingredients 
through  this regulatory proposal , nor is such an approach authorized by the 
statute .  As discussed above, this regulation establishes the naturally occurring 
level of lead for candy flavored with chili and/or tamarind, in accordance  with Page 9 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500Section 110552, subsections (c)(2) and (c)(3).  Regulation of lead  levels, 
including naturally occurring lead, in raw materials or foodstuff other than candy 
is outside the scope of the s tatute  and this regulatory action .
Commenters on the 2019 propo sed rulemaking also made recommendations on 
how the regulatory level should be implemented and enforce d.  For example,  
NCA  suggested a phased -in approach through a series of step -down levels over 
a period of several years  and that compliance should be bas ed on the average of 
multiple candy samples.  The NCA’s suggested approach of setting the “naturally 
occurring” regulatory level based on an average subject to an outlier limitation is 
also more appropriately viewed as a recommendation on compliance 
approa ches.  To the extent these recommendations address enforcement of the 
regulatory level, they are outside the scope of this rulemaking  and OEHHA’s 
authority under the statute.  Under Section 110552, subsection (e), CDPH is 
responsible for ensuring that cand y is not adulterated, including implementation 
and enforcement activities  related to lead in candy .  This includes establishing 
sampling and testing procedures in consultation with the Office of the Attorney 
General, testing samples of candy, adopting regu lations necessary for 
enforcement, and evaluating the regulatory process.  
One commenter  on the 2019 proposed rulemaking , the Center for Environmental 
Health  (CEH) , suggested  the proposed level is too high.   CEH commented that 
many  of the  available data sets  considered by OEHHA  include lead values that 
are mostly below the level of quantitation and that, i n the compiled product data 
evaluated, over 80% of the tested candies were contaminated with less than 10 
parts per billion ( ppb) lead.  CEH asserted that this is “clear evidence that 
through good agricultural, manufacturing, and procurement practices, lead 
contamination less than 10 ppb is feasible”.  Therefore, CEH concludes that a 
“level higher than 10 ppb is not appropriate”.   The natu rally occurring level of lead 
in candies flavored with chili and/or tamarind  proposed by OEHHA, 0.02 ppm  or 
20 ppb , was not determined from the available data on lead levels in candy 
products.  Rather, the naturally occurring level is based on  OEHHA’s evaluation 
of the level of naturally occurring lead that could reasonably be  contribute d by the 
following ingredients typically present in  these candies: chili peppers and chili 
powder, tamarind, food -grade salt, sugar, food -grad silicon dioxide, a nd food -
grade titanium dioxide , as described in the 2020 Technical Support Document .  
For all these reasons, OEHHA has determined that there is no alternative to the 
proposed regulation  that is less burdensome and equally effective in achieving Page 10 June 2020 
INITIAL STATEMENT  OF REASONS  
TITLE  27, CALIFORNIA  CODE  OF REGULATIONS  
ADOPTION O F NEW CHAPTER 3 , SECTION 28500the purpos es of the regulation in a manner that ensures full compliance with the 
authorizing statute.
Reasonable Alternatives to the Proposed Regulatory Action that Would 
Lessen Any Adverse Impact on Small Business and the Agency’s Reasons 
for Rejecting Those Alternatives
For the reasons discussed above, OEHHA has initially determined that no 
reasonable alternative considered by OEHHA, or that has otherwise been 
identified and brought to its attention , would be more effective in carrying out the 
proposed  action , or would be as effective and less burdensome to small 
business , or would be more cost -effective and equally effective in implementing 
the statutory policy or other provision of law  to small business.
Evidence Supporting Finding of No Significant Adverse Economic Impact 
on Business
The proposed regulation establishes a naturally occurring level for lead in candy 
containing chili and tamarind.  For the reasons noted above, this proposed  
regulatory action will not have a significant adverse economic impact on  
businesses within the State of California because very few California 
manufacturers of these candy products exist, and none are anticipated to be 
noncompliant with the proposed standard.  Further, of candies produced recently 
by Mexican manufacturers that  were tested for lead content between 2012 and 
2018, approximately 87% to 94% would be compliant with  the proposed level of 
0.02 ppm .  Additionally, OEHHA has determined the proposed  level is achievable 
by following good agricultural, manufacturing, and pr ocurement practices, or by 
other currently feasible practices  for California businesses  that would not pose 
significant costs  on these businesses . 
Efforts to Avoid Unnecessary Duplication or Conflicts with Federal 
Regulations Contained in the Code of Federal Regulations Addressing the 
Same Issues
OEHHA has determined that the  proposed regulation do es not duplicate and will 
not conflict with federal regulations. Although the FDA has published a guidance 
document concerning lead levels in candies frequen tly consumed by children, 
there are no current federal regulations  for naturally occurring levels of lead in 
candies flavored with  chili and /or tamarind .